BEUDAMED
    FDA Adverse Event Other Summary report: N

    VEST AIRWAY CLEARANCE SYSTEM, MODEL 104

    MDR report key: 1610969 · Received February 12, 2010

    Report

    Report Number
    1045510-2010-00003
    Event Type
    Other
    Date Received
    February 12, 2010
    Date of Event
    January 8, 2010
    Report Date
    January 15, 2010
    Manufacturer
    HILL-ROM, INC.
    Product Code
    BYI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (EVAL CODES WILL BE SUBMITTED UPON COMPLETION OF THE EVAL WITH THE FOLLOW UP REPORT).

    Description of Event or Problem · 1

    HILL-ROM HAS RECEIVED A REPORT THAT ALLEGES THE VEST WAS INVOLVED IN A FIRE. HILL-ROM'S COMPLAINT INVESTIGATION IS CURRENTLY UNDERWAY. AT THIS POINT, THE ORIGIN OF THE FIRE, AND WHETHER OR NOT THE VEST PRODUCT WAS INVOLVED IN THE CAUSE OF THE FIRE, REMAINS UNCERTAIN. AN INITIAL MEDICAL DEVICE REPORT IS BEING SENT TO THE FDA, AND A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VEST AIRWAY CLEARANCE SYSTEM, MODEL 104 POWERED PERCUSSOR BYI HILL-ROM, INC. 104

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR